Effect of probiotic supplementation in treatment of children with attention deficit hyperactivity disorder

Clinical trial of the effect of probiotic supplementation compared with the placebo on clinical status and metabolic profiles in children with attention deficit hyperactivity disorder undergoing Ritalin treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017090133941N16

Enrollment

Registered

2017-11-01

Start date

2017-06-05

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder. Disturbance of activity and attention

Interventions

Intervention 1: Intervention group: probiotic sachet (Takgen Company, Tehran, Iran) including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactoba

Eligibility

Sex/Gender

All

Age

8 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged between 8 and 12 years Patients diagnosed with attention deficit hyperactivity disorder based on DSM-IV criteria

Exclusion criteria

Exclusion criteria: mental disorders bipolar disorder pervasive developmental disorders autism not interested to be in research consuming probiotic yogurt, kefir and other fermented foods taking probiotic, antioxidant and/or anti-inflammatory supplements including vitamin E, vitamin C and omega-3 fatty acid taking antibiotics

Design outcomes

Primary

Measure	Time frame
ADHD rating scale. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Hamilton Anxiety Rating scale. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.;Depression. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.	—

Measure

Time frame

Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Hamilton Anxiety Rating scale. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.;Depression. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026